Protective Effect of Thymosin Α1 Against Negative Immune Dysregulation and Organ Dysfunction After Acute Aortic Dissection Surgery (PANDA II) (PANDA)

December 9, 2024 updated by: Hong Liu, Nanjing Medical University
Systemic inflammatory response syndrome (SIRS) and multiple organ dysfunction syndrome (MODS) are the major causes of death in patients with acute aortic syndrome (AAS). Therefore, the prevention of SIRS and MODS is of great clinical value, and immunomodulatory therapy with thymosin alpha 1 may be beneficial. This study was designed to test the hypothesis that the administration of thymosin alpha 1 during the acute phase of AAS will result in a reduced incidence of SIRS and MODS.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

330

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China, 10029
        • Recruiting
        • Beijing Anzhen Hospital Capital Medical University
        • Contact:
        • Contact:
        • Contact:
          • Si-chong Qian, MD
      • Guangzhou, China
        • Recruiting
        • The First Affiliated Hospital of Guangzhou Medical University
        • Contact:
        • Contact:
          • Ying-yuan Zhang, MD
      • Nanchang, China
        • Recruiting
        • The Second Affiliated Hospital of Nanchang University
        • Contact:
          • Zhi-hua Zeng, MD
        • Contact:
      • Shanghai, China
        • Recruiting
        • Shanghai East Hospital Tongji University
        • Contact:
        • Contact:
          • Guo-liang Fan, MD
      • Tianjin, China
        • Recruiting
        • Teda International Cardiovascular Hospital
        • Contact:
          • Lei Xi, MD
        • Contact:
    • Anhui
      • Bengbu, Anhui, China
        • Recruiting
        • The First Affiliated Hospital of Bengbu Medical College
        • Contact:
        • Contact:
          • Yi-yao Jiang, MD
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Contact:
        • Contact:
          • Xiao-kang Luo, MD
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • The First Affiliated Hospital of Nanjing Medical University
        • Contact:
        • Contact:
          • Hong Liu, MD
        • Contact:
          • Sheng Zhao, MD
      • Nanjing, Jiangsu, China
        • Recruiting
        • Nanjing First Hospital Nanjing Medical University
        • Contact:
        • Contact:
          • Fu-hua Huang, MD
      • Yangzhou, Jiangsu, China
        • Recruiting
        • Subei People's Hospital of Jiangsu province
        • Contact:
        • Contact:
          • Cheng-bin Tang, MD
    • Shandong
      • Jinan, Shandong, China
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:
          • Xin Zhao, MD
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • West China Hospital of Sichuan University
        • Contact:
        • Contact:
        • Contact:
          • Hong-hua Yue, MD
    • Xinjiang
      • Kazak, Xinjiang, China
        • Recruiting
        • The Friendship Hospital of Yili Kazak Autonomous Prefecture
        • Contact:
        • Contact:
          • Xiang-xiang Zheng, MD
      • Urumchi, Xinjiang, China
        • Recruiting
        • The Seventh Affiliated Hospital of Xinjiang Medical University
        • Contact:
        • Contact:
          • Xu-ran Lu, MD
    • Yunnan
      • Kunming, Yunnan, China
        • Recruiting
        • The First Affiliated Hospital of Kunming Medical University
        • Contact:
        • Contact:
          • Xiang-feng Bai, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • The patients are conformed to 2010 ACC/AHA guidelines for the diagnosis and treatment of thoracic aortic disease (TAD) within two weeks of onset;
  • Patients with acute aortic syndrome confirmed clinically and radiologically and planning to undergo emergency surgery were enrolled.
  • The patients' age between 18 ~90 years old.
  • Agree to participate in the study and sign the informed consent.

Exclusion Criteria:

  • Patients allergic to Thymosin α1;
  • Lactating women and pregnant women;
  • Patients with mental diseases, drug and alcohol dependence;
  • Refuse to participate in this study and refuse to sign the informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Thymosin alpha 1
1.6 mg q12h for 5 days
Drug: Thymosin Alpha1, 28A-Glycine-28B-L-Arginine-28C-L-Glutamic Acid-28D-L-Alanine-28E-L-Proline-28F-L-Alanine-28G-L-Asparagine-
Thymosin alpha 1, 1.6mg injection hypodermic (I.H), every 12 hours for 5 days at least during the ICU admission. The administration will be terminated any day during the treatment when the patient is deemed as qualified for ICU discharge or dead.
Sham Comparator: Blank control
Drug: Blank control
Blank control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The highest Sequential Organ Failure Assessment (SOFA) score of 7 days after surgery
Time Frame: 7 days after surgery
The occurrence of new-onset organ failure and new-onset persistent organ failure (Sequential Organ Failure Assessment (SOFA) score. New-onset is defined as events that occur after randomization and not present 24 hours before randomization.
7 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-day mortality
Time Frame: 30 days after randomization
Death from any cause of 30 days after randomization
30 days after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Medical University

Collaborators

Qilu Hospital of Shandong University
Nanjing First Hospital, Nanjing Medical University
Guangdong Provincial People's Hospital
Beijing Anzhen Hospital
The First Affiliated Hospital of Guangzhou Medical University
First Affiliated Hospital Bengbu Medical College
Second Affiliated Hospital of Nanchang University
Teda International Cardiovascular Hospital, Tianjin, China
West China Hospital Affiliated with Sichuan University
First Affiliated Hospital of Kunming Medical University
Shanghai East Hospital,Tongji University School of Medicine
Northern Jiangsu People's Hospital
The Seventh Affiliated Hospital of Xinjiang Medical University

Investigators

  • Principal Investigator: Hong Liu, Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

April 15, 2022

First Submitted That Met QC Criteria

April 15, 2022

First Posted (Actual)

April 21, 2022

Study Record Updates

Last Update Posted (Estimated)

December 12, 2024

Last Update Submitted That Met QC Criteria

December 9, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PANDA II

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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